Caring Relationships Expression Study

NCT05627687 | Completed Phase 1 DMC

• 1 other identifier: 00014913
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine a heart rate variability biofeedback (HRVB) intervention versus a music listening control (MLC) for 30 family caregivers (FCGs) of Alzheimer's disease (AD) (and related dementias: ADRD) patients to examine feasibility (acceptability/adherence, satisfaction) and direction of change in caregiver burden, stress, resilience, anxiety, self-compassion, and relationship quality over the course of 8-weeks.

Conditions

Caregiver Burden; Anxiety; Stress

Keywords

Heart Rate Variability; Biofeedback; Alzheimer's disease; Dementia

Outcome Measures

Primary Outcomes (2)

• Perceived Stress Scale-10 (PSS-10)

  10 items describing stress, response format 0-4, total score range 0-40, higher scores indicating worse stress

  Change from baseline to 8 weeks at end of intervention

• Caregiver Burden

  The Zarit Burden Interview includes 12 items, scoring from 0 to 4 (total range 0 to 48) with higher scores indicating higher perceived caregiver Burden

  Change from baseline to 8 weeks at end of intervention

Secondary Outcomes (4)

• The Brief Resilience Scale

  Change from baseline to 8 weeks at end of intervention

• Self-Compassion Scale

  Change from baseline to 8 weeks at end of intervention

• Relationship Quality

  Change from baseline to 8 weeks at end of intervention

• Depression

  Change from baseline to 8 weeks at end of intervention

Study Arms (2)

Music Listening Control

PLACEBO COMPARATOR

Music listening control (MLC) will consist of listening to selected music tracks of choice using either the Pandora or Spotify app (with coaching to download app and play, and log listening time in diary), specifically choosing a neutral channel, Coffeehouse Playlist. For both interventions, FCG will be asked to practice/listen 10-minutes at a time with their AD patient (sharing as much or as little as is possible/preferred) for at least 4-5 days/week, and asked to complete diary/checklists to show times practicing/listening.

Behavioral: Music Listening Control

Heart Rate Variability Biofeedback

ACTIVE COMPARATOR

Participants will receive coaching in a practice that is guided using an Inner Balance app with a device that senses pulse and provides feedback to help achieve a rhythm of heart rate variability called resonant frequency, or "coherence". They will be guided first in slowed heart-focused breathing and positively-focused emotions and then will connect to the app to receives visual feedback to achieve a favorable HRV.

Behavioral: Heart Rate Variability Biofeedback

Interventions

Heart Rate Variability Biofeedback BEHAVIORAL

Practice using the Inner Balance app and device, 10 minutes/day, 4-5 days per week

Also known as: Heart Focused breathing

Heart Rate Variability Biofeedback

Music Listening Control BEHAVIORAL

Listening to music using the Coffeehouse playlist on either Pandora or Spotify app, 10 minutes/day, 4-5 days per week

Music Listening Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In primary/unpaid FCG role \> 6 months
• Caring for mild-to-severe ADRD patient
• caregiver burden score Own/operate smartphone w data plan

You may not qualify if:

• Pacemakers or implanted cardioconverter defibrillator (ICD), or conditions/meds that interfere with HRV measurement/feedback

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

Arizona State University Downtown Campus

Phoenix, Arizona, 85004, United States

Location

MeSH Terms

Conditions

Caregiver Burden; Anxiety Disorders; Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Study Officials

• Linda K Larkey, PhD

  Arizona State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participant is advised that they are entering a study in which they will be randomized to one of two conditions designed to potentially reduce stress and caregiver burden. Neither condition is presented as the control, thus participants are blinded to the expectations of the assigned condition.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a two-arm parallel randomized controlled trial comparing heart rate variability biofeedback to a music listening control condition, both practiced 4-5 days per week for 8 weeks.

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: November 28, 2022
• Study Start: December 13, 2021
• Primary Completion: February 28, 2023
• Study Completion: July 1, 2023
• Last Updated: February 12, 2024

Record last verified: 2024-02

Locations

US (1)